Registration Dossier

Administrative data

Description of key information

Skin irritation: negative

Eye Irritation: causes irreversible effects

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

γ-butyrolactone (GBL) has been adequately tested for skin and eye irritation and found to not be a skin irritant but is capable of causing irreversible effects in the eye. When applied to clipped Vienna White rabbits and occluded, mean Erythema and Edema scores were 0 out of 4 after 24, 48, and 72 hours (BASF AG, 1960). When applied to an eye of a single New Zealand White rabbit in an OECD 405 guideline study under GLP conditions, effects on the cornea were observed (BASF AG, 2005). The mean cornea score was 1.3 out of 4 after 24, 48, and 72 hours, and were not fully reversible after 28 days. Similar results were observed in an earlier study of similar design (BASF, 1960) and are further supported by several in vitro tests. However, another OECD 405 guideline study, under GLP conditions, reported in the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) Technical Report No. 48 (Version 2), indicated that effects observed in the cornea were reversible within 14 days (ECETOC, 1998), but some details of the study design were not available for review. GBL should be regarded as an eye irritant capable of causing irreversible effects.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation

Based on the results of the key study (Draize score = 0 after 24, 48 and 72 hours under occlusive conditions), gamma-butyrolactone would not be classified as a primary dermal irritant under the EU DSD criteria (EU Directive 67/548/EEC) or under the EU CLP criteria (EU Regulation 1272/2008).

Eye irritation

When applied to the eye of a rabbit, effects on the cornea were observed. The mean cornea score was 1.3 out of 4 after 24, 48, and 72 hours and was not fully reversible after 28 days. Based on the results of the key study gamma-butyrolactone would be classified as Xi; R41 (Risk of serious damage to eyes) under the EU DSD criteria (EU Directive 67/548/EEC). Gamma-butyrolactone also meets the criteria for classification as a Category 1 eye irritant (Causes serious eye damage) under the EU CLP criteria (EU Regulation 1272/2008) because the effects were not fully reversible after 28 days.